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Executive Summary

OTC HYDROCORTISONE MARKETING SHOULD BE LIMITED TO 1% STRENGTHS, COMBE maintained in April 20 comments on FDA's proposal to allow OTC marketing of 0.25-1% hydrocortisone products. FDA's proposal, published on Feb. 27, would switch 0.5-1% hydrocortisone products from prescription to OTC status; hydrocortisone is already permitted to be marketed OTC in 0.25-0.5% strengths. Combe, which manufactures the 0.5% OTC hydrocortisone product Lanacort, argues that OTC marketing should be limited to the 1% strength because it is "the lowest effective dose for the labeled OTC indications." The firm cited a number of studies that FDA relied on in proposing the Rx-to-OTC switch as well as a recently completed survey of 103 dermatologists. The survey, conducted for Combe by the Syosset, New York-based market research firm Beta Research Corporation, found that 87% of responding dermatologists believe 1% hydrocortisone is either effective (34%) or minimally effective (53%), while only 39% believe that the 0.5% strength is either effective (8%) or minimally effective (31%). For the 0.25% hydrocortisone strength, 3% of the dermatologists said they believe the dosage is effective, and 16% said it is minimally effective. Noting that no companies currently market a 0.25% strength of hydrocortisone, presumably because of lack of efficacy, Combe maintained that permitting a wide range of OTC strengths of hydrocortisone would cause consumer confusion. "No rational use distinctions, understandable to the OTC purchaser are possible," the firm said, "because the labeling in the proposal for all hydrocortisone concentrations from 0.25 to 1% is identical." Combe also pointed out that consumers might initially purchase a lower cost, low concentration product and then switch to a higher dose product if unsatisfied. That situation, the company said, "will almost invariably cause them to exceed the seven-day hydrocortisone use limit." The company proposes that FDA allow a year long phase-out period for low concentration products after publication of a final rule permitting OTC marketing of 1% hydrocortisone.



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